Jynarque
These highlights do not include all the information needed to use JYNARQUE safely and effectively. See full prescribing information for JYNARQUE. JYNARQUE (tolvaptan) tablets, for oral use Initial U.S. Approval: 2009
Approved
Approval ID
3febc0a1-9e5a-4ce0-843d-210f21d862c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2022
Manufacturers
FDA
Otsuka America Pharmaceutical, Inc.
DUNS: 008314390
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tolvaptan
PRODUCT DETAILS
NDC Product Code59148-079
Application NumberNDA204441
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateOctober 23, 2020
Generic Nametolvaptan
tolvaptan
PRODUCT DETAILS
NDC Product Code59148-082
Application NumberNDA204441
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 23, 2020
Generic Nametolvaptan
INGREDIENTS (9)
TOLVAPTANActive
Quantity: 15 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
tolvaptan
PRODUCT DETAILS
NDC Product Code59148-087
Application NumberNDA204441
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateOctober 23, 2020
Generic Nametolvaptan
tolvaptan
PRODUCT DETAILS
NDC Product Code59148-089
Application NumberNDA204441
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateOctober 23, 2020
Generic Nametolvaptan
tolvaptan
PRODUCT DETAILS
NDC Product Code59148-080
Application NumberNDA204441
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateOctober 23, 2020
Generic Nametolvaptan
tolvaptan
PRODUCT DETAILS
NDC Product Code59148-088
Application NumberNDA204441
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateOctober 23, 2020
Generic Nametolvaptan
tolvaptan
PRODUCT DETAILS
NDC Product Code59148-083
Application NumberNDA204441
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 23, 2020
Generic Nametolvaptan
INGREDIENTS (9)
TOLVAPTANActive
Quantity: 30 mg in 1 1
Code: 21G72T1950
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT